Received May 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 5 | CT3Z7 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 5JX2E | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 4H297 | — |
Higher than Approved Dose (Overdose); Extra dose administered; 2nd dose administered at longer interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adult patient who received HBV (Engerix B) (batch number CT3Z7, expiry date 13-FEB-2027) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis and HBV (Engerix B) (batch number 4H297, expiry date 06-APR-2026) for prophylaxis. Previously administered products included Engerix B (1st dose received on 12-OCT-2023 with lot number-XS278, expiry date-17-Mar-2025) and Engerix B (3rd dose received on 05-SEP-2024 with lot number 92NK2, expiry date- 29-SEP-2026). On 11-APR-2025, the patient received the 5th dose of Engerix B. On 05-MAR-2025, the patient received the 4th dose of Engerix B. On 12-MAR-2024, the patient received the 2nd dose of Engerix B. On 12-MAR-2024, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose administered at longer interval). On 05-MAR-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered). On 11-APR-2025, the patient experienced extra dose administered (Verbatim: Higher than Approved Dose (Overdose)). The outcome of the extra dose administered, extra dose administered and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 21-APR-2025 Physician Assistant reported he/she had a patient who was given five vaccines for Hepatitis B, Engerix B and just wanted to go over any potential actions that should be take in place for any potential side effects from this. The patient received 2nd dose at longer interval than recommended which led to lengthening of vaccination schedule. The patient received 4th and 5th dose not as per schedule which led extra dose administered. The reporter did not consent to follow-up.